The FDA review process for Plan B emergency contraceptive was found to be mired in political and ideological dogma divorced from accepted science in rejecting the recommendations of both FDA officials and an advisory committee, deferring the final decision to upper managers and failing to properly document the review and decision-making timeline.
2005.11.15
Officials with the Food and Drug Administration reviewing an application to allow over-the-counter sales of emergency contraception strayed from the normal approval in four significant ways, according to a report released yesterday by the Government Accountability Office. The report sparked charges from some in Congress and outside groups supporting broader contraception access that the FDA review process for Plan B was mired in a political and ideological dogma divorced from accepted science.
According to the GAO report, the FDA conducted the Plan B review in a manner quite different from reviews of 64 other over-the-counter cases between 1994 and 2004, specifically by rejecting the recommendations of both FDA officials and an advisory committee, deferring the final decision on Plan B to upper managers, failing to properly document the review and decision-making timeline and utilizing a “novel,” non-traditional rationale to explain the application denial.
The agency differs with the GAO report on three of the issues: the involvement of high-level managers, the timeframe of the 2004 decision and the GAO assertion that the FDA’s rationale was “novel.”. As of press time, the FDA has not released an official statement on the issue, and other news outlets have reported no success in obtaining comment from agency officials.
In a statement yesterday, Advocates for Youth, a group working for broader education on sex-related issues, pointed to the GAO report as evidence that the Bush administration has allowed “ultra-conservative allies” to have an extraordinary influence on executive branch policies.
“This report shows the FDA’s decision on EC was ‘unusual,’ at best,” Advocates for Youth President James Wagoner said in the statement. “In other words, it had nothing to do with imposing consistent standards of public health and everything to do with appeasing the administration’s conservative base.”
Wagoner added that the report “substantiates the claims of the FDA’s deputy in charge of women’s health, Dr. Susan Wood, who recently resigned charging that the decision to block EC was clearly based on politics rather than the science behind the issue.”
Complaining of political interference in the emergency-contraception decision, Wood abruptly resigned her post at the end of August, shortly after the agency said it was not yet ready to issue a conclusion on Barr Laboratories’ application to sell the medication without a prescription. The FDA has repeatedly deferred a final decision on the issue since originally rejecting Barr’s application last year.
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Author: Brendan Coyne
News Service: The NewStandard
URL: http://newstandardnews.net/content/?action=show_item&itemid=2597&x=x
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